Toltarox 50 mg/ml Oral Suspension for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Toltrazuril

Available from:

Krka d.d., Novo Mesto

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Pharmaceutical form:

Oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antiprotozoal anticoccidial

Authorization status:

Expired

Authorization date:

2011-09-27

Summary of Product characteristics

Revised: August 2015
AN: 01318/2015
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Toltarox 50 mg/ml oral suspension for pigs (Belgium, Denmark, Germany,
Ireland,
Netherlands, Romania, Slovenia, United Kingdom)
Toltarox vet 50 mg/ml oral suspension for pigs (Finland, Sweden)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral suspension contains:
ACTIVE SUBSTANCE:
Toltrazuril
50 mg
EXCIPIENTS:
Sodium benzoate (E211)
2.1 mg
Sodium propionate (E281) 2.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Thick white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (Piglet 3 – 5 days old).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of clinical signs of coccidiosis in neonatal
piglets (3 - 5 days) on
farms with a confirmed history of coccidiosis caused by _Isospora
suis_.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide, frequent and repeated use of
antiprotozoals from the
same class may lead to the development of resistance.
Revised: August 2015
AN: 01318/2015
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None known.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Wash any splashes from skin or eyes immediately with water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known, e.g. there is no interaction in combination with iron
supplementation.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral use.
Individual animal treatment.
Each piglet to be treated on day 3 to 5 of life with a single oral
dose of 20 mg
toltrazuril per kg bodyweight corresponding to 0.4 ml oral suspension
per kg
bodyw